Methods for the elimination of scars using copolymer films in place of surgical sutures

ABSTRACT

Copolymer films are used in place of surgical sutures. When applied to the live skin these copolymer films not only protect skin wounds and injuries but also take the place of traditional stitching of wounds at the end of surgical operations, aid healing and eliminate scars. The copolymers may be applied in liquid form by a dropper or syringe or may be applied on the skin as an aerosol.

United States Patent [1 1 Bernaola l METHODS FOR THE ELIMINATION OF SCARS USING COPOLYMER FILMS IN PLACE OF SURGICAL SUTURES [76] Inventor: Omar A. Bernaola, Departmento de Fisica, Universidad de Oriente,

Cumana Edo Sucre, Venezuela 22 Filed: Jan.26, 1972 211 Appl. No.: 220,887

[52] US. Cl 128/334 R, 128/156, 424/78 [51] Int. Cl A6lb 17/00 [58] Field of Search 128/334 R, 335, 335.5,

[56] References Cited UNITED STATES PATENTS 8/1957 Gallienne et al 128/156 X 6/1972 Halpern 128/334 R Nov. 12, 1974 OTHER PUBLICATIONS Choy et al., US. Armed Forces Med. Jour., Vol. 111, No. 9, pp. l,24ll,255.

Primary ExaminerDalton L, Truluck Attorney, Agent, or FirmBrowne, Beveridge, DeGrandi & Kline [57] ABSTRACT 10 Claims, 6 Drawing Figures INVENTION M'USCULAR TISSUE PATENTEUHUV 2 1914 I 3847', 1 55 FIG 2 p MUSCULAR TISS FIG. 3 FIG. 4

PRIOR ART MUSCULAR TISSUE METHODS FOR THE ELIMINATION OF SCARS USING COPOLYMER FILMS IN PLACE OF SURGICAL SUTURES BACKGROUND OF THE INVENTION The present invention relates to drug and bodytreating compositions and in particular to film-forming compositions used in place of surgical sutures for treating wounds in live or living skin.

The traditional process of closing wounds such as at the end of surgical operations by sewing the edges of the wound together with a strand or fiber is well known. Securing the edges of the wound protects the area from infection and promotes healing. Unfortunately, the traditional method of sewing the edges of the wound suffers from many disadvantages. For example, the skin must be pierced and the fiber inserted about the edges of the wound, thus leading to possible further infection. In addition, certain types of wounds, such as burns, are not easily susceptible to traditional suturing techniques. The stitching must be done by a skilled physician or surgeon lest the wound heal leaving a permanent scar on the patient. Then, too, the strand or fiber must be removed only at the correct time, after the healing process is completed but before the skin grows over the fiber.

It is the principal object of this invention to use a synthetic resin copolymer film to replace surgical stitching, join the edges of a wound and promote healing without leaving polymeric material therebetween.

It is a feature of the invention to replace surgical clamps, staples, and other sutures with an easily applied liquid synthetic resin copolymer.

It is a further feature of the invention to use an improved synthetic resin film to protect injured areas of the skin from abrasion and infection.

It is a further feature of the invention to eliminate scars in the healing of wounds.

It is a further feature of the invention to treat tissue infections and external ulcers with a synthetic resin film which is a bactericide and which promotes rapid healmg.

It is a further feature of the invention to treat the umbilical cord with a synthetic resin film to promote the healing process.

It is a further feature of the invention to eliminate the need for tissue transplants in treating burns and external wounds by using a synthetic resin film to promote healing.

SUMMARY OF THE INVENTION Briefly, in accordance with the invention, a new method of promoting the healing of wounds, burns, external ulcers and the like, without the need for traditional surgical suturing is disclosed. A synthetic resin Wounds covered by films formed by these synthetic resin copolymer compositions are protected from further infection. Because films thus formed are flexible, a large degree of mobility is permitted even when covering a wound located near a joint. Protected by such a film, the injured area is immersed in natural fluids which promote the healing process. Not only does the wound heal more rapidly, but the possibility of scars is eliminated. Although these films adhere tightly to the skin surrounding the wound, they do not adhere to the injured area itself. Thus no polymer is trapped in the wound as it heals. Thisis an important feature of the invention and prevents any possible toxic hypersensitivity reaction, which might be obtained with compositions such as those illustrated in FIGS. 1-5. Furthermore, the instant synthetic resin copolymer films are not affected by soaps, detergents, alcohol, antiseptics and most liquids normally encountered in medical treatment.

BRIEF DESCRIPTION OF DRAWINGS Polymeric compositions previously employed to join joint tissue surfaces have left polymeric material between the edges of the healing wound as illustrated in FIGS. 1-5. This often results in a toxic hypersensitivity reaction, causing discomfort to the patient and preventing the wound from healing. FIG. 1 illustrates the joining of skin by a polymeric material which adheres beneath one layer of skin and above the other. FIG. 2 illustrates a polymer composition which envelopes both sides of part of the skin surrounding a wound and which I adheres to the upper surface of another section of the skin. FIG. 3 illustrates another polymeric composition which does not adhere tightly enough to the skin to join the edges of the wound together and further allows the polymeric material to enter the wound. FIG. 4 illus trates a polymeric composition which joins the lower surface of one portion of the skin surrounding the wound to the upper surface of another portion of the skin. Finally, FIG. 5 illustrates a polymeric composition which adheres only to the upper surface of part of the skin surrounding the wound and in addition enters into the wound.

In sharp contrast to the prior art, the films formed by the instant synthetic resin copolymer composition are illustrated in FIG. 6. It is shown that the film adheres tightly to the surface of the skin surrounding the wound, but does not enter the wound. Because the instant films do not adhere to the wound, the healing process is enhanced as natural fluids are allowed to surround the injured area. Thus the formation of granulation tissue is avoided. Because these films do not enter the wound, the possiblilty of a toxic hypersensitivity reaction is avoided.

DETAILED DESCRIPTION OF THE INVENTION or mixtures thereof. The amount of the synthetic resin copolymer composition dissolved in the solvent mixture ranges from one to 50 percent by weight.

In addition to the preferred copolymers defined above, a mixture of polyvinyl chloride with polyvinyl acetate in the stated proportions may also be used. still further, the copolymer of vinyl chloride and vinyl acetate may be mixed with polyvinyl chloride and polyvinyl acetate so that the ratios of vinyl chloride and vinyl acetate are as stated above. They can be applied at room temperature and are observed to dry to form an impervious film in a short time without the need of a catalyst. The resulting film is not affected by water, alcohol, soaps, detergents, antiseptics and most liquids normally encountered in medical treatment. Furthermore, the film is stable over the entire range of pH at temperatures less than 70 C. The film protects injured areas of the skin from abrasion and infection for periods lasting from days to 6 months depending upon the precise composition used.

The area to be treated is covered with the liquid copolymer composition by means of a dropper, cotton swab, or atomizer spray. After a short time, about three minutes at room temperature, the solvent mixture evaporates and a continuous solid film forms which adheres tightly to the skin. The film is transparent and permits a continual observation of the area under treatment. v

Experiments have been performed on guinea pigs, rats, cattle, pigs, dogs and humans by making an incision from one to 10 centimeters long involving the subcutaneous tissue. The edges of the wound are brought together and the liquid copolymer composition is applied directly to form a uniform covering extending at least one-half centimeter past the edges of the wound. Afterapproxirnately 3 minutes a continuous solid film forms which adheres tightly to the skin excluding air and all liquids which might hear infection-causing organisms. No further treatment is needed.

This method permits the injured area to remain bathed in natural fluids, allows a wound to heal rapidly, eliminates scars and leaves no polymeric material in the wound. Because of this, the healing of'the wound occurs in a very different manner from that observed when using a composition which leaves substantial amounts of polymeric material in the wound. Use of polymer films which leave substantial amounts of polymeric material in the wound, illustrated in FIGS. 1S, may result in the-patients exhibiting a toxic hypersensitivity reaction. Furthermore, granulation tissue is often formed.

The following examples further illustrate the invention.

EXAMPLE I HEALING OF BURNS WITHOUT TISSUE TRANSPLANTATION weight vinyl acetate, and 1 percent by weight maleic acid in interpolymerized form. Burned areas protected by such a film were observed to heal more rapidly and with less inflammation than similar burns which were not protected. For example, burns approximately 2 centimeters in diameter were observed to heal in approximately a 30 percent shorter time than similar burns not so protected.

The final appearance of the burned area after healing is much improved when burns are treated by the instant synthetic resin copolymer compositions. This is particularly true where the epidermis has not been altered or where the altered cells have been eliminated.

In cases where the epidermis of the burned area has been eliminated, leaving only edges of living skin, the burned area is covered with a physiological serum and this area with its surrounding edges is then covered with a copolymer film of the instant invention. Thus, the edges of the living skin are closed under an air-tight and liquid-tight film and remains in a liquid which is favorable to skin growth.

A burn which was approximately 2 centimeters in diameter treated with these copolymer films was observed to close in approximately 10 days for. humans and 6 days for guinea pigs, which may be compared to no healing of the burn in 15 days for humans and guinea pigs for a similar burn not treated with these copolymer films.

If the copolymer film remains intact and unbroken during the period of healing, the wound is observed to close in a circular form ending in a dot and leaving almost no observable scar.

EXAMPLE II HEALING OF THE UMBILICAL CORD Experiments have been performed on. newborn guinea pigs, pigs, cattle and human infants. After normal cleaning of theumbilical cord, the area is covered with an inert solvent containing a copolymer composition made from approximately 15 percent by weight vinyl acetate, 84 percent by weight vinyl chloride, 0.5 percent by weight maleic acid in interpolymerized form. After evaporation of the solvent, the composition forms an air-tight and liquid-tight film which protects the entire area. The evolution of the healing of the umbilical cord is observed to be much faster and no cases of infection have been observed. Furthermore, the umbilical cord loosens and drops off in a time 10 to 50 percent shorter than that which is normally observed and the external appearance of the final scar is greatly improved. It has been observed that human umbilical cords treated according to the instant invention loosen and drop off in. approximately 2 days to 5 days as compared to approximately 5 to 10 days to umbilical cords not so treated.

EXAMPLE III ELIMINATION OF SCARS It is a feature of the instant invention that it permits the elimination of scars in the healing of external sutures and further permits the elimination of old scars.

The formation of the scar which is normally observed upon the healing of a sutured wound following a surgical operation is basically due to the fact that during the process of healing, the cells within the wound are subjected to different stressed tensions produced by the suture stitches. By means of the instant invention, a copolymer film is formed on the surface of the skin which distributes in a uniform manner the stresses on the cells within the wound area. Thus, all the cells within the wound area are permitted to close under similar conditions. This eliminates the formation of scars normally observed after the healing of asutured wound following a surgical operation.

Two incisions approximately centimeters long, were made on guinea pigs and rats'. One incision was treated with an inert solvent containing a copolymer composition containing percent by weight vinyl acetate, and 85 percent by weight vinyl chloride in interpolymerized form. Approximately 3 minutes after application of the solution at 30 C., an air-tight and liquid-tight film was observed to form. The incision treated with the copolymer was observed to heal without leaving a scar in approximately 5 days while the incision not so treated was observed to heal in approximately 9 days leaving an unsightly scar visible.

Old scars may be treated by surgical elimination of the cells of the old scar leaving only living and normal cells. The edges of the living skin is immersed in a physiological serum by covering the zone with a copolymer film formed from a copolymer composition containing approximately 15 percent by weight vinyl acetate, 85 percent by weight vinyl chloride in interpolymerized form. Upon treatment with this method, no granulation of the tissue is observed and in 90 percent of the cases no visible scar is left.

EXAMPLE IV TREATMENT OF SKIN INFECTIONS AND EXTERNAL ULCERS It is another feature of the instant invention that it permits treatment of all kinds of skin infections and external ulcers. Thearea to be treated is cleaned and disinfected thoroughly and medicinal agents may be applied in the conventional manner. The whole area is then covered with an inert solvent containing a copolymer composition made from approximately 14 percent by weight vinyl acetate, 85 percent byweight vinyl chloride, and 1 percent by weight maleic acid in interpolymerized form. After evaporation of the solvent the compositionforms an air-tight, and liquid-tight film which protects the entire area.

The patient may wear normal clothes without danger of irritation or contamination of the treated area and since the film is not affected by water, the patient may wash and bathe the treated area without danger. The healing of the treated area may be directly observed as the film is transparent and the healing is further found to be much faster than similar area not so treated. Furthermore, it is a feature of the instant invention that medicines supplied before the application of the copolymer compositions are retained within the treated area, aiding treatment of infections.

It is understood that various other modifications will be apparent and can readily be made by those skilled in the art without departing from the scope and spirt of this invention. Accordingly, it is not intended that the scope of the claims appended hereto be limited to the description set forth herein, but rather that the claims be construed as encompassing all the features of patentable novelty which reside in the presentinvention,

including all featureswhich would be treated as the equivalent thereof by those skilled in the art to which the invention pertains.

I claim: 1. A method of promoting healing of the umbilical cord consisting of:

cleaning said umbilical cord, applying a composition comprising an inert solvent and a synthetic resin copolymer composition to said umbilical cord, said synthetic resin copolymer composition consisting essentially of up to 99 percent by weight vinyl chloride, up to 50 percent by weight vinyl acetate and 0 to 20 percent by weight maleic acid, and vaporizing said solvent whereby a continuous synthetic resin film selected from the group consisting of interpolymers of vinyl chloride, vinyl acetate and maleic acid, copolymers of vinyl chloride and vinyl acetate, mixtures of polyvinyl chloride and said interpolymers, mixtures of polyvinyl acetate and said interpolymers, mixtures of polyvinyl chloride and said copolymers, and mixtures of polyvinyl acetate and said copolymers, is formed enveloping said umbilical cord and promoting the healing thereof.

2 The method according to claim 1 in which said synthetic resin copolymer composiition consists essentially of 5 to 20 percent by weight vinyl acetate, to percent by weight vinyl chloride and 0.2 to 10 percent by weight maleic acid.

3. The method according to claim 1 in which said synthetic resin copolymer composition consists essentially of up to 50 percent by weight vinyl acetate and up to 99 percent by weight vinyl chloride.

4. The method according to claim 1 in which the amount of said synthetic resin copolymer composition dissolved in said solvent ranges from one to 50 per cent by weight.

5. A method for the elimination of scars in the heal-- ing of a sutured wound, consisting of:

surgically eliminating scar cells leaving edges of normal skin tissues; bringing said edges of normal skin tissues together; applying a composition on and about said edges of normal skin tissues comprising an inert solvent and a synthetic resin copolymer composition consisting essentially of up to 99 percent by weight vinyl chloride, up to 50 percent by weight vinyl acetate, and 0 to 20 by weight maleic acid; and

vaporizing said solvent whereby a continuous synthetic resin film selected from the group consisting of interpolymers of vinyl chloride, vinyl acetate and maleic acid, copolymers of vinyl chloride and vinyl acetate, mixtures of polyvinyl chloride and said interpolymers, mixtures of polyvinyl acetate and said interpolymers, mixtures of polyvinyl chloride and said copolymers, and mixtures of polyvinyl acetate and said copolymers, is formed which adheres tightly to said skin tissues surrounding said wound but does not enter said wound itself.

6. The method according to claim 5 in which said synthetic resin copolymer composition consists essentially of 5 to 2 0 percent by weight vinyl acetate, 80 to 95 percent by weight vinyl chloride and 0.2 to 10 percent by weight maleic acid.

7.. The method according to claim 5 in which said synthetic resin copolymer composition consists esseninert solvent and a synthetic resin copolymer composition.

10. The method according to claim 5 including applying a sufficient amount of said composition comprising an inert solvent and a synthetic resin copolymer composition to cover said wound and to extend at least one half centimeter beyond said edges of said wound. 

1. A METHOD OF PROMOTING HEALING OF THE UMBILICAL CORD CONSISTING OF: CLEANING SAID UMBILICAL CORD, APPLYING A COMPOSITION COMPRISING AN INERT SOLVENT AND A SYNTHETIC RESIN COPOLYMER COMPOSITION TO SAID UMBILICAL CORD, SAID SYNTHETIC RESIN COPOLYMER COMPOSITION CONSISTING ESSENTIALLY OF UP TO 99 PERCENT BY WEIGHT VINYL CHLORIDE, UP TO 50 PERCENT BY WEIGHT VINYL ACETATE AND 0 TO 20 PERCENT BY WEIGHT MALEIC ACID, AND VAPORIZING SAID SOLVENT WHEREBY A CONTINUOUS SYNTHETIC RESIN FILM SELECTED FROM THE GROUP CONSISTING OF INTERPOLYMERS OF VINYL CHLORIDE, VINYL ACETATE, AND MALEIC ACID, COPOLYMERS OF VINYL CHLORIDE AND VINYL ACETATE, MIXTURES OF POLYVINYL CHLORIDE AND SAID INTERPOLYMERS, MIXTURES OF POLYVINYL ACETATE AND SAID INTERPOLYMERS, MIXTURES OF POLYVINYL CHLORIDE AND SAID COPOLYMERS, AND MIXTURES OF POLYVINYL ACETATE AND SAID COPOLYMERS, IS FORMED ENVELOPING SAID UMBILICAL CORD AND PROMOTING THE HEALING THEREOF.
 2. The method according to claim 1 in which said synthetic resin copolymer composiition consists essentially of 5 to 20 percent by weight vinyl acetate, 80 to 95 percent by weight vinyl chloride and 0.2 to 10 percent by weight maleic acid.
 3. The method according to claim 1 in which said synthetic resin copolymer composition consists essentially of up to 50 percent by weight vinyl acetate and up to 99 percent by weight vinyl chloride.
 4. The method according to claim 1 in which the amount of said synthetic resin copolymer composition dissolved in said solvent ranges from one to 50 per cent by weight.
 5. A method for the elimination of scars in the healing of a sutured wound, consisting of: surgically eliminating scar cells leaving edges of normal skin tissues; bringing said edges of normal skin tissues together; applying a composition on and about said edges of normal skin tissues comprising an inert solvent and a synthetic resin copolymer composition consisting essentially of up to 99 percent by weight vinyl chloride, up to 50 percent by weight vinyl acetate, and 0 to 20 by weight maleic acid; and vaporizing said solvent whereby a continuous synthetic resin film selected from the group consisting of interpolymers of vinyl chloride, vinyl acetate and maleic acid, copolymers of vinyl chloride and vinyl acetate, Mixtures of polyvinyl chloride and said interpolymers, mixtures of polyvinyl acetate and said interpolymers, mixtures of polyvinyl chloride and said copolymers, and mixtures of polyvinyl acetate and said copolymers, is formed which adheres tightly to said skin tissues surrounding said wound but does not enter said wound itself.
 6. The method according to claim 5 in which said synthetic resin copolymer composition consists essentially of 5 to 20 percent by weight vinyl acetate, 80 to 95 percent by weight vinyl chloride and 0.2 to 10 percent by weight maleic acid.
 7. The method according to claim 5 in which said synthetic resin copolymer composition consists essentially of up to 50 percent by weight vinyl acetate and up to 99 by weight vinyl chloride.
 8. The method according to claim 5 in which the amount of said synthetic resin copolymer composition dissolved in said solvent ranges from one to 50 per cent by weight.
 9. The method according to claim 5 including covering the edges of normal skin tissues with a physiological serum before applying said composition comprising an inert solvent and a synthetic resin copolymer composition.
 10. The method according to claim 5 including applying a sufficient amount of said composition comprising an inert solvent and a synthetic resin copolymer composition to cover said wound and to extend at least one half centimeter beyond said edges of said wound. 